Senior CAPA Specialist de Elstree em Stryker Corporation

Data de Postagem: 11/24/2019

Resumo do Emprego

Descrição do Emprego

Main purpose of role:

Primarily responsible for supporting the NC/CAPA process and procedures, and ensure it is compliant, effective, and efficiency in dealing with quality issues. Facilitates proactive and effective resolution of issues through expertise in problem-solving methodology.

Key tasks:

  • Ensure compliance to CAPA processes and procedures.
  • Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
  • Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
  • Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, etc.).
  • Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
  • Ensure adequate training is maintained, and provided to all users of CAPA process and systems
  • Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement.
  • Support Stryker internal, Corporate, and third party audit activities.

Qualifications, skills and desirable experience:

  • BS in a science, engineering or related discipline.
  • Preferred working knowledge and understanding of U.S. and International medical device regulations and supporting Quality Systems (audits, management review, quality planning, etc.)
  • Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
  • Strong written and oral communication and negotiation skills.
  • Strong critical thinking skills.
  • Highly developed problem-solving skills.
  • Strong analytical skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently.

Work From Home: Not available

Travel Percentage: 0%

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